QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, First and Only Syndromic Solution Integrating Detection of SARS-CoV-2 Coronavirus

First syndromic testing solution to be deployed in epidemic can differentiate novel coronavirus from 21 other serious respiratory infections

QIAstat-Dx Respiratory SARS-CoV-2 Panel delivers results in about one hour

Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response

March 31, 2020 04:05 AM Eastern Daylight Time

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.

The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.

“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States under the FDA’s emergency use authorization for clinical laboratories. The QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Chief Executive Officer at QIAGEN. “I am proud of our QIAGEN teams working tirelessly to implement 24/7 production of test cartridges and testing components. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands as well as numerous components and instruments for use in fighting this public health crisis around the world.”